Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure
|ClinicalTrials.gov Identifier: NCT00124969|
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : May 9, 2008
Patients with end-stage renal failure have a markedly higher mortality because of cardiovascular events in comparison with the normal population. Disorders in the calcium metabolism, such as calcification of the vessel walls, occur very frequently. There are indications that calcium channel blockers are capable of lowering the cardiovascular mortality in patients with end-stage renal failure.
It is intended to carry out a prospective, randomized, double-blind, placebo-controlled, multicenter study in order to find out if the calcium channel blocker amlodipine is able to reduce the mortality of patients with end-stage renal failure.
The investigation will be carried out after suitable explanation and written informed consent in 356 patients aged between 18 and 90 years with end-stage renal failure and chronic haemodialysis treatment. The patients will be randomized to either treatment with amlodipine 10 mg/day or placebo. The occurrence of events will be documented and evaluated prospectively over a period of 30 months.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Failure, Chronic||Drug: Amlodipine Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||356 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Influence of Amlodipine on the Mortality of Patients With End-Stage Renal Failure (ADAM [Amlodipine and Dialysis Patients, Action on Mortality])|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||October 2006|
Active Comparator: 1
Other Name: Placebo
Placebo Comparator: 2
- The primary outcome will be the survival rate. The secondary outcome will be cardiovascular events. [ Time Frame: Prospective: look forward using periodic observations collected predominantly following subject enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124969
|Charite Campus Benjamin Franklin|
|Berlin, Germany, 12200|
|Principal Investigator:||Martin Tepel, Dr||Charite Campus Benjamin Franklin|